Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM) (TRACE-AI Yale)

February 4, 2026 updated by: Yale University

Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM): TRACE-AI Prospective Study

The TRACE-AI Diagnostic Study will evaluate the performance of artificial intelligence (AI) models applied to electrocardiograms (AI-ECG) and echocardiograms (AI-Echo) to identify transthyretin amyloid cardiomyopathy (ATTR-CM) in adults with heart failure. Model performance will be validated through comparison with technetium-99m pyrophosphate (PYP) imaging results.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale New Haven Health System
        • Principal Investigator:
          • Rohan Khera, MD, MS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include participants from the YNHHS who were identified in Phase I of the TRACE-AI study. Eligible individuals must have a confirmed diagnosis of HFpEF or HFmrEF, 75 with a positive AI-based screening result from both AI-ECG and AI-Echo and 75 with a negative AI-based screen, and no prior diagnostic work-up for cardiac amyloidosis.

Description

Inclusion Criteria:

  • Patients 18 years or older with at least one of each component cardiovascular diagnosis testing (ECG and Echo) in the YNHHS.
  • Patients with a diagnosis of HFpEF or HFmrEF
  • Participant from Phase I TRACE-AI Study with AI-ECG and AI-Echo screen in the preceding 36 months

Exclusion Criteria:

  • Patients who have opted out of research studies
  • Patients with cardiac amyloid diagnostic test in the past 36 months
  • Patients with hypertrophic cardiomyopathy or end-stage renal disease
  • Pregnant women
  • Patients unable or unwilling to provide informed consent
  • Non-English speakers and cognitively impaired individuals who are unable to comprehend the consent and the on-screen instructions on the application, which are in English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of the sequential screening approach
Time Frame: From enrollment through completion of PYP scan at baseline study visit
Measured by the positive predictive value (PPV) of the test for ATTR-CM, based on confirmatory imaging and clinical testing
From enrollment through completion of PYP scan at baseline study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Bridgebio Pharma, Inc

Investigators

  • Principal Investigator: Rohan Khera, MD, MS, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 3, 2025

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000039677

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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